FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/02/049367 [Registered on: 01/02/2023] Trial Registered Prospectively
Last Modified On: 31/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   An observational study of Menstrual pattern in shift duty working women 
Scientific Title of Study   An observational study of Rajo-pravrutti pattern in shift duty working women 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kirti Hanumant Jadhav 
Designation  PG Student 
Affiliation  PDEAs College Of Ayurveda and Research Centre,Nigdi,Pune 44 
Address  Department of Swasthavritta and Yoga, PDEAs College of Ayurveda and Research Centre, Nigdi, Pune

Pune
MAHARASHTRA
411044
India 
Phone  9822465715  
Fax    
Email  drkirtijadhav@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajkumar Bobade 
Designation  HOD 
Affiliation  PDEAs College Of Ayurveda and Research Centre,Nigdi,Pune 44 
Address  Department of Swasthavritta and Yoga, PDEAs College Of Ayurveda and Research Centre, Nigdi, Pune

Pune
MAHARASHTRA
411044
India 
Phone  9447319234  
Fax    
Email  rajkumarbobade@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kirti Hanumant Jadhav 
Designation  PG Student 
Affiliation  PDEAs College Of Ayurveda and Research Centre,Nigdi,Pune 44 
Address  Department of Swasthavritta and Yoga, PDEAs College of Ayurveda and Research centre, Nigdi, Pune

Pune
MAHARASHTRA
411044
India 
Phone  9822465715  
Fax    
Email  drkirtijadhav@gmail.com  
 
Source of Monetary or Material Support  
PDEAs College Of Ayurveda and Research Centre, Sector no 25, Nigdi ,Pune 
 
Primary Sponsor  
Name  PDEAs College of Ayurveda and Research Centre 
Address  Nigdi Pune 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kirti Jadhav  PDEAs College of Ayurveda and Research Centre  Department of Swasthavritta, Room No 123B, PDEAs College of Ayurveda and Research Centre, Sector No 25, Nigdi, Pune 411044
Pune
MAHARASHTRA 
9822465715

drkirtijadhav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Menstrual pattern will be studied in women working in rotational shifts for more than 6 months 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Working for more than 6 months in shift duties 
 
ExclusionCriteria 
Details  Pregnant women and lactating mothers
Subjects with major illnesses malignancy, HIV, tuberculosis.
Subjects using hormonal drugs oral contraception pills,
progesterone, oestrogen, glucocorticoid 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study would reveal the effects 0f working in shift duties on menstrual pattern.  52 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The study would reveal frequent gynecological pathologies occurring in women working in shifts.  52 weeks 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/02/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Ayurveda considers Nidra (sleep) as one among the three sub pillars of life which helps in the maintenance of the body, along with Aahara (food) and Brahmacharya(sexual life). All Acharyas are having the similar opinion that
various aspects of happiness and sorrow, nourishment and emaciation, strength and weakness, knowledge and ignorance, life and death are all dependent upon sleep. Nidra is considered as one among the thirteen Adharaneeya Vegas. Shift work sleep disorders can be discussed under diseases due to Nidra Vegarodha (suppression of sleep), Nidra Naasha (insomnia) and Akaala Shayana (untimely sleep). As the natural urge for sleep in the night is being suppressed in relation with shift works, Nidra Vegarodha Janya Vikaraas (diseases due to suppression of sleep) are having significant role. Most disorders of female reproductive system are due to Vata Dosha vitiation. According to WHO, occupational health deals with all aspects of health and safety in the work place and has a strong focus on primary prevention of hazards.Circadian rhythms are physical, mental, and behavioral changes that follow a 24-hour cycle. Circadian rhythms can influence important functions in our bodies, such as: Hormone release, eating habits and digestion, body temperature. Increasingly, shift work and night work are becoming more common in our so called “24-hour” (or “24/7”) society. This results in the sleep loss and misalignment of circadian rhythm with respect to sleep wake cycle. Studies of regular night-shift workers indicate that the circadian timing system usually fails to adapt successfully to such inverted schedules. Additional problems include higher rates of cancer and of cardiac, gastrointestinal and reproductive disorders in chronic night shift workers. The duration and pattern of menstrual cycle are considered as women’s reproductive health indicators.
 
Close